FDA Panel Backs Astellas Pharma's Overactive Bladder Drug

Tokyo-based Astellas Pharma Inc. (ALPMF.PK) announced Thursday that its proposed drug for treating overactive bladder - Mirabegron, won the backing of an FDA advisory panel.

Overactive Bladder, or OAB for short, is a urological condition that causes a sudden and unstoppable need to urinate, even if only a small amount of urine is present in the bladder.

Astellas' Mirabegron is a once daily oral selective ß3-adrenoceptor agonist designed to improve the storage capacity of the bladder without diminishing bladder contraction during bladder voiding.

The FDA panel, which reviewed the Mirabegron NDA, voted 7 to 4 with 1 abstention, recommending approval of the drug for the treatment of overactive bladder. The final decision of the FDA is set for June 29, 2012. Though not binding, the FDA usually considers the recommendations of its advisory panels.

Regulatory applications for Mirabegron are also under review in several other countries. In July 2011, Mirabegron was granted marketing approval in Japan and was launched last September.

More than 30 million Americans have OAB, and the annual OAB prescription market in the United States is valued at about $2.0 billion by pharmaceutical market research firm IMS Health Inc.

Some of the FDA-approved drugs for overactive bladder include, Astellas' very own Solifenacin sold under the brand name Vesicare; Novartis' (NVS) Darifenacin, marketed under the brand name Enablex; Pfizer Inc.'s (PFE) Fesoterodine marketed under the trade name Toviaz; Tolterodine sold under the brand names Detrol, Detrol LA and Trospium sold under brand names Sanctura and Sanctura XR; Watson Pharmaceuticals Inc.'s (WPI) Oxybutynin marketed under the brand names Ditropan, Ditropan XL, Oxytrol and a topical gel called Gelnique.

Last December, the FDA approved Antares Pharma Inc.'s (AIS) Anturol, a topical gel, for the treatment of OAB.

According to a report by Global Industry Analysts Inc., over 200 million people worldwide are estimated to be affected by overactive bladder. The global market for overactive bladder drug therapies is projected to be in excess of $4.0 billion by the year 2017.